Efficacy and Tolerability of Armodafinil in Adults With Excessive Sleepiness Associated With Shift Work Disorder

Excessive Sleepiness Clinical Trial

Official title:

A Randomized, Double-Blind, Placebo-Controlled Study to Evaluate the Efficacy and Tolerability of Armodafinil Treatment (150 mg) in Improving Clinical Condition Late in the Shift and in Improving Functional and Patient-Reported Outcomes in Adult Patients With Excessive Sleepiness Associated With Shift Work Disorder

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01080807
• Other study ID #: C10953/4030
• Status: Completed
• Phase: Phase 4
• First received: March 3, 2010
• Last updated: May 17, 2012
• Start date: March 2010
• Est. completion date: October 2010

Study information

• Verified date: May 2012
• Source: Teva Pharmaceutical Industries
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug Administration
• Study type: Interventional

Clinical Trial Summary

The primary objective of the study is to determine whether armodafinil treatment is more effective than placebo treatment in patients with excessive sleepiness associated with shift work disorder (SWD) by measuring improved clinical condition late in the shift, including the commute home.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 385
• Est. completion date: October 2010
• Est. primary completion date: October 2010
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 65 Years

Eligibility

Inclusion Criteria:

1. The patient currently meets the criteria for Shift Work Disorder (SWD) for duration of at least 1 month.

2. The patient has the presence of excessive sleepiness late in the shift, including the commute home if applicable, with a Clinical Global Impression of Severity of Illness (CGI-S) rating of 4 or more at screening.

3. The patient has clinically significant difficulty in social or occupational functioning, with a Global Assessment of Function (GAF) score less than 70 (on clinician interview) at screening.

4. The patient has a Karolinska Sleepiness Scale (KSS) score of 6 or more at screening (visit 1) that is confirmed at baseline (visit 2).

5. The patient works at least 5 night shifts per month, of which at least 3 nights are consecutive, and plans to maintain this schedule.

6. The patient works night shifts or rotating shifts that include at least 6 hours between 2200 and 0800 (including the time period 0400 to 0800), and shifts are no longer than 12 hours in duration.

7. The patient is in good health, as judged by the investigator.

8. The patient is able to complete self-rating scales.

9. Women of childbearing potential (not surgically sterile or 2 years postmenopausal), must use a medically accepted method of contraception, and must continue use of 1 of these methods for the duration of the study (and for 30 days after participation in the study). Acceptable methods of contraception include: abstinence, barrier method with spermicide, steroidal contraceptive (oral, transdermal, implanted, and injected) in conjunction with a barrier method, or intrauterine device (IUD).

10. The patient is willing and able to comply with study restrictions and to attend regularly scheduled clinic visits as specified in this protocol

Exclusion Criteria:

1. The patient has mild or more severe obstructive sleep apnea (OSA) defined as an apnea/hypopnea index more than 5 as determined by daytime polysomnography (PSG).

2. The patient has a medical or psychiatric disorder causing clinically significant functional impairment or contributing to the patient's excessive sleepiness.

3. The patient is currently taking a medication or substance that is causing clinically significant functional impairment or contributing to the patient's excessive sleepiness.

4. The patient has a clinically significant treated or untreated medical condition.

5. The patient has a history of clinically significant suicidal ideation in the judgment of the principal investigator or is currently suicidal based on medical and psychiatric history.

6. The patient has a known hypersensitivity to armodafinil, racemic modafinil, or any component of the study drug tablets.

7. The patient has a history of any clinically significant cutaneous drug reaction, or a history of clinically significant hypersensitivity reaction, including multiple allergies or drug reactions.

8. The patient consumes caffeine including coffee, tea and/or other caffeine containing beverages or food averaging more than 600 mg of caffeine per day within 7 days of the baseline visit.

9. The patient uses any prescription or over-the-counter (OTC) drugs disallowed by the protocol within 30 days of the baseline visit.

10. The patient has been in a prior armodafinil study.

11. The patient has a history of alcohol, narcotic, or any other drug abuse.

12. The patient has a positive urine drug screen (UDS) without medical explanation at the screening visit.

13. The patient has a clinically significant deviation from normal on physical examination.

14. The patient is a pregnant or lactating woman.

15. The patient has used an investigational drug within 1 month of the screening visit.

16. The patient has a disorder that could interfere with the absorption, distribution, metabolism, or excretion of the investigational product.

17. The patient needs to use any of the excluded medications in this protocol.

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Disorders of Excessive Somnolence
• Excessive Sleepiness

Intervention

Drug:
• Armodafinil
At the baseline visit, patients who continued to meet eligibility criteria were randomly assigned (1:1) to receive either 150 mg of armodafinil or matching placebo treatment only on nights worked for 6 weeks. Study drug was taken once nightly, 30 to 60 minutes prior to the start of the night shift, on nights worked. Armodafinil treatment was titrated as follows (only on nights worked): the first dose was 50 mg (1 tablet), the second and third doses were 100 mg (2 tablets), and the fourth and subsequent doses were 150 mg (3 tablets). Placebo tablets matching armodafinil tablets were administered on the same schedule.
• Matching Placebo
At the baseline visit, patients who continued to meet eligibility criteria were randomly assigned (1:1) to receive either 150 mg of armodafinil or matching placebo treatment only on nights worked for 6 weeks. Study drug was taken once nightly, 30 to 60 minutes prior to the start of the night shift, on nights worked. Armodafinil treatment was titrated as follows (only on nights worked): the first dose was 50 mg (1 tablet), the second and third doses were 100 mg (2 tablets), and the fourth and subsequent doses were 150 mg (3 tablets). Placebo tablets matching armodafinil tablets were administered on the same schedule.

Locations

Country	Name	City	State
United States	Neurotrials Research Inc	Atlanta	Georgia
United States	Sleep Disorders Center of Georgia-Peachtree	Atlanta	Georgia
United States	FutureSearch Trials of Neurology	Austin	Texas
United States	North Coast Clinical Trials Inc	Beachwood	Ohio
United States	PAB Clinical Research	Brandon	Florida
United States	Sleep Health Center	Brighton	Massachusetts
United States	Southeastern PA Medical Institute	Broomall	Pennsylvania
United States	Peninsula Sleep Center	Burlingame	California
United States	Helene A. Emsellem, MD	Chevy Chase	Maryland
United States	Chicago Research Center	Chicago	Illinois
United States	Community Research Inc	Cincinnati	Ohio
United States	Tri State Sleep Disorders Center	Cincinnati	Ohio
United States	SleepMed of South Carolina	Columbia	South Carolina
United States	Community Research	Crestview	Kentucky
United States	The Center for Sleep and Wake Disorders d/b/a Midwest Neuro	Danville	Indiana
United States	Duke Insomnia & Sleep Research Program	Durham	North Carolina
United States	Suburban Lung Associates	Elk Grove Village	Illinois
United States	Fort Wayne Neurological Center	Fort Wayne	Indiana
United States	Avastra Clinical Trials	Fountain Valley	California
United States	Sleep Disorders Center of Georgia-Gainesville	Gainesville	Georgia
United States	Mid-South Neurology Center	Germantown	Tennessee
United States	MD Clinical	Hallandale Beach	Florida
United States	The Center for Sleep Medicine	Hattiesburg	Mississippi
United States	Central Arkansas Research	Hot Springs	Arkansas
United States	Goldpoint Clinical Research	Indianapolis	Indiana
United States	Rehabilitation Associates of Indiana	Indianapolis	Indiana
United States	University of Iowa Hospitals	Iowa City	Iowa
United States	Consolidated Clinical Trials	Jefferson Hills	Pennsylvania
United States	Kingwood Research Institute	Kingwood	Texas
United States	Clinical Research Center of Nevada	Las Vegas	Nevada
United States	Somnos Laboratories, Inc d/b/a Somnos Clinical Research	Lincoln	Nebraska
United States	Clinical Study Centers LLC	Little Rock	Arkansas
United States	Pacific Sleep Medicine Services Inc	Los Angeles	California
United States	Kentucky Research Group	Louisville	Kentucky
United States	Sleepmed Inc	Macon	Georgia
United States	North Star Medical Research LLC	Middleburg Heights	Ohio
United States	Avastra Clinical Trials	Midvale	Utah
United States	CliniLabs Inc	New York	New York
United States	Lynn Health Science Institute	Oklahoma City	Oklahoma
United States	Compass Research LLC	Orlando	Florida
United States	Vince and Associates Clinical Research	Overland Park	Kansas
United States	Southwestern Research Inc	Pasadena	California
United States	Broward Research Group	Pembroke Pines	Florida
United States	CRI Worldwide	Philadelphia	Pennsylvania
United States	REM Medical Sleep Center	Phoenix	Arizona
United States	Wake Research Associates	Raleigh	North Carolina
United States	Pacific Sleep Medicnie Services Inc	Redlands	California
United States	Stanford University Medical Center	Redwood City	California
United States	St Mary's of Michigan	Saginaw	Michigan
United States	Sleep Therapy and Research Center	San Antonio	Texas
United States	Dormir Clinical Trials, Inc.	San Diego	California
United States	Southwestern Research Inc	Santa Ana	California
United States	St Johns Medical Plaza Sleep Disorders Center	Santa Monica	California
United States	Miami Research Associates	South Miami	Florida
United States	Florida Sleep Institute	Spring Hill	Florida
United States	Clayton Sleep Institute LLC	St Louis	Missouri
United States	Washington University Sleep Medicine Center	St Louis	Missouri
United States	Clinical Research Group of St Petersburg	St Petersburg	Florida
United States	Sleep Lab of Northeastern PA	Summit Hill	Pennsylvania
United States	SomnoMedics	Tampa	Florida
United States	Mercy St Anne Sleep Disorder Center	Toledo	Ohio
United States	REM Medical Clinical Research	Tucson	Arizona
United States	Wake Forest University Health Sciences	Winston-Salem	North Carolina

Sponsors (1)

Lead Sponsor	Collaborator
Cephalon

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Percentage of Patients With at Least Minimal Improvement From Baseline in the Clinical Global Impression of Change (CGI-C) Rating as Related to Late Shift Sleepiness at Endpoint	The Clinical Global Impression of Change (CGI-C) is an assessment performed by the clinician, evaluating the change in the patient's symptoms over time. The clinician categorizes the change as: very much improved, much improved, minimally improved, no change, minimally worse, much worse, or very much worse. The data presented here represents the percentage of patients whose condition showed at least minimal improvement in the CGI-C rating as related to late shift sleepiness (defined as the period 0400-0800, including the commute home).	Baseline and week 6 (or last observation after baseline)	No
Secondary	Change From Baseline to Endpoint in Global Assessment of Function (GAF) Score	The Global Assessment of Functioning (GAF) is a numeric scale (0 through 100) used by the clinician to rate the social, occupational, and psychological functioning of the patient. A higher score indicates superior functioning and fewer symptoms. The data presented here represents the mean change from baseline to endpoint in the GAF scores of each group.	Baseline and week 6 (or last observation after baseline)	No
Secondary	Change From Baseline to Week 3 in Global Assessment of Functioning	The Global Assessment of Functioning (GAF) is a numeric scale (0 through 100) used by the clinician to rate the social, occupational, and psychological functioning of the patient. A higher score indicates superior functioning and fewer symptoms. The data presented here represents the mean change from baseline in the GAF scores of each group.	Baseline and Week 3	No
Secondary	Change From Baseline to Week 6 in Global Assessment of Functioning	The Global Assessment of Functioning (GAF) is a numeric scale (0 through 100) used by the clinician to rate the social, occupational, and psychological functioning of the patient. A higher score indicates superior functioning and fewer symptoms. The data presented here represents the mean change from baseline in the GAF scores of each group.	Baseline and Week 6	No
Secondary	Change From Baseline to Endpoint in the Mean Karolinska Sleepiness Scale (KSS) Score	The Karolinska sleepiness scale is a 10-point scale, on which the participant has to mark his sleepiness during the previous 10 minutes. The scale ranges from 1, which indicates "extremely alert", to 10, which indicates "extremely sleepy, can't stay awake". The KSS was performed by the participant at the baseline visit, week 3, and week 6 (or early termination visit). The score recorded is the average of 3 assessments within ±15 minutes at 0400, 0600, and 0800. The data presented here represents the mean change from baseline in the KSS scores of each group.	Baseline and week 6 (or last observation after baseline)	No
Secondary	Change From Baseline to Week 3 in the Mean Karolinska Sleepiness Scale (KSS) Score	The Karolinska sleepiness scale is a 10-point scale, on which the participant has to mark his sleepiness during the previous 10 minutes. The scale ranges from 1, which indicates "extremely alert", to 10, which indicates "extremely sleepy, can't stay awake". The KSS was performed by the participant at the baseline visit, week 3, and week 6 (or early termination visit). The score recorded is the average of 3 assessments within ±15 minutes at 0400, 0600, and 0800. The data presented here represents the mean change from baseline in the KSS scores of each group.	Baseline and week 3	No
Secondary	Change From Baseline to Week 6 in the Mean Karolinska Sleepiness Scale (KSS) Score	The Karolinska sleepiness scale is a 10-point scale, on which the participant has to mark his sleepiness during the previous 10 minutes. The scale ranges from 1, which indicates "extremely alert", to 10, which indicates "extremely sleepy, can't stay awake". The KSS was performed by the participant at the baseline visit, week 3, and week 6 (or early termination visit). The score recorded is the average of 3 assessments within ±15 minutes at 0400, 0600, and 0800. The data presented here represents the mean change from baseline in the KSS scores of each group.	Baseline and week 6	No
Secondary	Percentage of Patients With at Least Minimal Improvement From Baseline in the Clinical Global Impression of Change (CGI-C) Rating as Related to Late Shift Sleepiness at Week 3	The Clinical Global Impression of Change (CGI-C) is an assessment performed by the clinician, evaluating the change in the patient's symptoms over time. The clinician categorizes the change as: very much improved, much improved, minimally improved, no change, minimally worse, much worse, or very much worse. The data presented here represents the percentage of patients whose condition showed at least minimal improvement in the CGI-C rating as related to late shift sleepiness (defined as the period 0400-0800, including the commute home).	Baseline and week 3	No
Secondary	Percentage of Patients With at Least Minimal Improvement From Baseline in the Clinical Global Impression of Change (CGI-C) Rating as Related to Late Shift Sleepiness at Week 6	The Clinical Global Impression of Change (CGI-C) is an assessment performed by the clinician, evaluating the change in the patient's symptoms over time. The clinician categorizes the change as: very much improved, much improved, minimally improved, no change, minimally worse, much worse, or very much worse. The data presented here represents the percentage of patients whose condition showed at least minimal improvement in the CGI-C rating as related to late shift sleepiness (defined as the period 0400-0800, including the commute home).	Baseline and week 6	No
Secondary	Change From Baseline to Endpoint in the Modified Sheehan Disability Scale (MSDS) Composite Score	Mental-health related disability was assessed with the Modified Sheehan Disability Scale (MSDS). The MSDS has three 11-point items, and the participant is asked to rate, on a numerical scale, the extent to which emotional problems have disrupted her/his work, social life, and family life/home responsibilities over the last month. Each item is rated from 0, indicating "not at all", to 10, indicating "extremely". Scores for the items are summed for a possible score of 0 to 30. The MSDS was performed by the patient at the baseline visit, at Week 3, and at Week 6.	Baseline and week 6 (or last observation after baseline)	No
Secondary	Change From Baseline to Endpoint in the Modified Sheehan Disability Scale (MSDS) Work Item Score	Mental-health related disability was assessed with the Modified Sheehan Disability Scale (MSDS). The MSDS has three 11-point items, and the participant is asked to rate, on a numerical scale, the extent to which emotional problems have disrupted her/his work, social life, and family life/home responsibilities over the last month. Each item is rated from 0, indicating "not at all", to 10, indicating "extremely". Scores for the items are summed for a possible score of 0 to 30. The MSDS was performed by the patient at the baseline visit, at Week 3, and at Week 6.	Baseline and week 6 (or last observation after baseline)	No
Secondary	Change From Baseline to Endpoint in the Modified Sheehan Disability Scale (MSDS) Social Life Item Score	Mental-health related disability was assessed with the Modified Sheehan Disability Scale (MSDS). The MSDS has three 11-point items, and the participant is asked to rate, on a numerical scale, the extent to which emotional problems have disrupted her/his work, social life, and family life/home responsibilities over the last month. Each item is rated from 0, indicating "not at all", to 10, indicating "extremely". Scores for the items are summed for a possible score of 0 to 30. The MSDS was performed by the patient at the baseline visit, at Week 3, and at Week 6.	Baseline and week 6 (or last observation (or last observation after baseline))	No
Secondary	Change From Baseline to Endpoint in the Modified Sheehan Disability Scale (MSDS) Family Life Item Score	Mental-health related disability was assessed with the Modified Sheehan Disability Scale (MSDS). The MSDS has three 11-point items, and the participant is asked to rate, on a numerical scale, the extent to which emotional problems have disrupted her/his work, social life, and family life/home responsibilities over the last month. Each item is rated from 0, indicating "not at all", to 10, indicating "extremely". Scores for the items are summed for a possible score of 0 to 30. The MSDS was performed by the patient at the baseline visit, at Week 3, and at Week 6.	Baseline and week 6 (or last observation after baseline)	No
Secondary	Change From Baseline to Endpoint in the Modified Sheehan Disability Scale (MSDS) Score - Days Missed Work or Unable to Carry Out Responsibilities	Mental-health related disability was assessed with the Modified Sheehan Disability Scale (MSDS). The MSDS has three 11-point items, and the participant is asked to rate, on a numerical scale, the extent to which emotional problems have disrupted her/his work, social life, and family life/home responsibilities over the last month. Each item is rated from 0, indicating "not at all", to 10, indicating "extremely". Scores for the items are summed for a possible score of 0 to 30. The MSDS was performed by the patient at the baseline visit, at Week 3, and at Week 6.	Baseline and week 6 (or last observation after baseline)	No
Secondary	Change From Baseline to Endpoint in the Modified Sheehan Disability Scale (MSDS) Score - Number of Days of Reduced Productivity	Mental-health related disability was assessed with the Modified Sheehan Disability Scale (MSDS). The MSDS has three 11-point items, and the participant is asked to rate, on a numerical scale, the extent to which emotional problems have disrupted her/his work, social life, and family life/home responsibilities over the last month. Each item is rated from 0, indicating "not at all", to 10, indicating "extremely". Scores for the items are summed for a possible score of 0 to 30. The MSDS was performed by the patient at the baseline visit, at Week 3, and at Week 6.	Baseline and week 6 (or last observation after baseline)	No
Secondary	Treatment Satisfaction Questionnaire for Medication (TSQM)- Effectiveness Score at Endpoint	TSQM is a 14 question questionnaire assessing satisfaction with the medication. 4 scales are generated: side effects, effectiveness, convenience, and global satisfaction. Subjects responded to the questionnaire at Week 3, Week 6, and last observation after baseline. Optional responses are: Extremely Dissatisfied, Very Dissatisfied, Dissatisfied, Somewhat Satisfied, Satisfied, Very Satisfied, and Extremely Satisfied. From the responses, a scale score from 0 - 100 is calculated, with a higher score indicating greater satisfaction. Results from the Effectiveness scale are presented here.	Endpoint	No
Secondary	Treatment Satisfaction Questionnaire for Medication (TSQM)- Side Effects Score at Endpoint	TSQM is a 14 question questionnaire assessing satisfaction with the medication. 4 scales are generated: side effects, effectiveness, convenience, and global satisfaction. Subjects responded to the questionnaire at Week 3, Week 6, and last post-baseline observation. Optional responses are: Extremely Dissatisfied, Very Dissatisfied, Dissatisfied, Somewhat Satisfied, Satisfied, Very Satisfied, and Extremely Satisfied. From the responses, a scale score from 0 - 100 is calculated, with a higher score indicating greater satisfaction. Results from the Side Effects scale are presented here.	Endpoint	No
Secondary	Treatment Satisfaction Questionnaire for Medication (TSQM)- Convenience Score at Endpoint	TSQM is a 14 question questionnaire assessing satisfaction with the medication. 4 scales are generated: side effects, effectiveness, convenience, and global satisfaction. Subjects responded to the questionnaire at Week 3, Week 6, and last observation after baseline. Optional responses are: Extremely Dissatisfied, Very Dissatisfied, Dissatisfied, Somewhat Satisfied, Satisfied, Very Satisfied, and Extremely Satisfied. From the responses, a scale score from 0 - 100 is calculated, with a higher score indicating greater satisfaction. Results from the Convenience scale are presented here.	Endpoint	No
Secondary	Treatment Satisfaction Questionnaire for Medication (TSQM)- Global Satisfaction Score at Endpoint	TSQM is a 14 question questionnaire assessing satisfaction with the medication. 4 scales are generated: side effects, effectiveness, convenience, and global satisfaction. Subjects responded to the questionnaire at Week 3, Week 6, and last observation after baseline. Optional responses are: Extremely Dissatisfied, Very Dissatisfied, Dissatisfied, Somewhat Satisfied, Satisfied, Very Satisfied, and Extremely Satisfied. From the responses, a scale score from 0 - 100 is calculated, with a higher score indicating greater satisfaction. Results from the Global Satisfaction scale are presented here.	Endpoint	No
Secondary	Change From Baseline to Endpoint in the Functional Outcomes of Sleep Questionnaire (FOSQ-10) Total Score	FOSQ-10 consists of 10 questions, on a scale of 1-4(1=extreme difficulty 4=no difficulty), measures impact of sleepiness on activities of daily living. Lower score = more difficulty with activity due to lack of sleep. Total score = MEAN of subscale scores (vigilance, productivity, social outcome, intimacy, activity) multiplied by 5. Worst total score is 5 (maximum difficulty) the best is 20 (no difficulty). This data reports CHANGE in total score from baseline to endpoint, with higher (positive) values representing improvement. Worst possible CHANGE value would be -15 best would be +15.	Baseline and week 6 (or last observation after baseline)	No
Secondary	Change From Baseline to Endpoint in the Functional Outcomes of Sleep Questionnaire (FOSQ-10) Activity Level Score	FOSQ-10 consists of 10 questions rated on a scale of 1 to 4 (1=extreme difficulty and 4=no difficulty), and is used to measure the impact of daytime sleepiness on activities of daily living and quality of life. A total score and 5 subscale (vigilance, general productivity, social outcome, intimacy, and activity level) scores are calculated from the responses. Worst subscale score is 1 (maximum difficulty) and the best score is 4 (no difficulty). This score represents the CHANGE from Baseline in the Activity level subscale. Positive change scores represent improvement (possible range -3 to +3).	Baseline and week 6 (or last observation after baseline)	No
Secondary	Change From Baseline to Endpoint in the Functional Outcomes of Sleep Questionnaire (FOSQ-10) General Productivity Score	FOSQ-10 consists of 10 questions rated on a scale of 1-4 (1=extreme difficulty, 4=no difficulty), and is used to measure the impact of daytime sleepiness on activities of daily living and quality of life. A total score and 5 subscale (vigilance, general productivity, social outcome, intimacy, and activity level) scores are calculated from the responses. Worst subscale score is 1 (maximum difficulty) and the best score is 4 (no difficulty). This score represents the CHANGE from Baseline in the General Productivity subscale. Positive change scores represent improvement (possible range -3 to +3).	Baseline and week 6 (or last observation after baseline)	No
Secondary	Change From Baseline to Endpoint in the Functional Outcomes of Sleep Questionnaire (FOSQ-10) Vigilance Score	FOSQ-10 consists of 10 questions rated on a scale of 1-4 (1=extreme difficulty, 4=no difficulty), and is used to measure the impact of daytime sleepiness on activities of daily living and quality of life. A total score and 5 subscale (vigilance, general productivity, social outcome, intimacy, and activity level) scores are calculated from the responses. Worst subscale score is 1 (maximum difficulty) and the best score is 4 (no difficulty). This score represents the CHANGE from Baseline in the Vigilance subscale. Positive change scores represent improvement (possible range -3 to +3).	Baseline and week 6 (or last observation after baseline)	No
Secondary	Change From Baseline to Endpoint in the Functional Outcomes of Sleep Questionnaire (FOSQ-10) Social Outcome	FOSQ-10 consists of 10 questions rated on a scale of 1-4 (1=extreme difficulty, 4=no difficulty), and is used to measure the impact of daytime sleepiness on activities of daily living and quality of life. A total score and 5 subscale (vigilance, general productivity, social outcome, intimacy, and activity level) scores are calculated from the responses. Worst subscale score is 1 (maximum difficulty) and the best score is 4 (no difficulty). This score represents the CHANGE from Baseline in the Social Outcome subscale. Positive change scores represent improvement (possible range -3 to +3).	Baseline and week 6 (or last observation after baseline)	No
Secondary	Change From Baseline to Endpoint in the Functional Outcomes of Sleep Questionnaire (FOSQ-10) Intimacy	FOSQ-10 consists of 10 questions rated on a scale of 1-4 (1=extreme difficulty, 4=no difficulty), and is used to measure the impact of daytime sleepiness on activities of daily living and quality of life. A total score and 5 subscale (vigilance, general productivity, social outcome, intimacy, and activity level) scores are calculated from the responses. Worst subscale score is 1 (maximum difficulty) and the best score is 4 (no difficulty). This score represents the CHANGE from Baseline in the Intimacy subscale. Positive change scores represent improvement (possible range -3 to +3).	Baseline and week 6 (or last observation after baseline)	No